NCT01307462: FAM for BOS

Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant

Completed Phase 2 Results posted Last updated 6 September 2017

What this trial tests

Phase 2 trial testing fluticasone propionate in Bronchiolitis Obliterans in 36 participants. Completed in 1 December 2015.

Timeline

1 June 2011

Primary endpoint
1 September 2014

1 December 2015

Quick facts

Lead sponsor	Stephanie Lee
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 June 2011
Primary completion	1 September 2014
Estimated completion	1 December 2015
Sites	11 locations across United States

Drugs / interventions tested

• fluticasone propionate (FLUTICASONE PROPIONATE) — full drug profile →
• montelukast sodium — full drug profile →
• azithromycin (azithromycin) — full drug profile →

Conditions studied

• Bronchiolitis Obliterans — all drugs for Bronchiolitis Obliterans →

Sponsor

Stephanie Lee

Who can join

Adults 6 to 99, any sex, with Bronchiolitis Obliterans. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Subjects Who Failed Treatment
  Time frame: Within 3 months after initiation of study medications
  Treatment failure is defined as sustained, absolute decrease (worsening) of the FEV1 by \>= 10% predicted in comparison to the baseline FEV1. Must be confirmed by a second PFT 2 weeks after the first measurement.

Sponsor's own description

This phase II trial studies how well giving fluticasone propionate, azithromycin, and montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans who previously underwent stem cell transplant. FAM may be an effective treatment for bronchiolitis obliterans

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fluticasone, Azithromycin, and Montelukast Treatment for New-Onset Bronchiolitis Obliterans Syndrome after Hematopoietic Cell Transplantation.
   Williams KM, Cheng GS, Pusic I, Jagasia M, et al · · 2016 · cited 148× · PMID 26475726 · DOI 10.1016/j.bbmt.2015.10.009
2. Pulmonary symptoms measured by the national institutes of health lung score predict overall survival, nonrelapse mortality, and patient-reported outcomes in chronic graft-versus-host disease.
   Palmer J, Williams K, Inamoto Y, Chai X, et al · · 2014 · cited 73× · PMID 24315845 · DOI 10.1016/j.bbmt.2013.11.025
3. Bronchiolitis obliterans syndrome after allogeneic hematopoietic SCT: phenotypes and prognosis.
   Bergeron A, Godet C, Chevret S, Lorillon G, et al · · 2013 · cited 66× · PMID 23208317 · DOI 10.1038/bmt.2012.241
4. Fibrotic and sclerotic manifestations of chronic graft-versus-host disease.
   Kitko CL, White ES, Baird K. · · 2012 · cited 26× · PMID 22226112 · DOI 10.1016/j.bbmt.2011.10.021
5. A Critical Care and Transplantation-Based Approach to Acute Respiratory Failure after Hematopoietic Stem Cell Transplantation in Children.
   Elbahlawan L, Srinivasan A, Morrison RR. · · 2016 · cited 19× · PMID 26409244 · DOI 10.1016/j.bbmt.2015.09.015
6. Relevance of Plasma Matrix Metalloproteinase-9 for Bronchiolitis Obliterans Syndrome after Allogeneic Hematopoietic Cell Transplantation.
   Inamoto Y, Martin PJ, Onstad LE, Cheng GS, et al · · 2021 · cited 17× · PMID 34126278 · DOI 10.1016/j.jtct.2021.06.006
7. Delivering macrolide antibiotics to heal a broken heart - And other inflammatory conditions.
   Venditto VJ, Feola DJ. · · 2022 · cited 10× · PMID 35367307 · DOI 10.1016/j.addr.2022.114252
8. The Development of New Agents for Post-Hematopoietic Stem Cell Transplantation Non-Infectious Complications in Children.
   Ilan U, Brivio E, Algeri M, Balduzzi A, et al · · 2023 · cited 2× · PMID 36983151 · DOI 10.3390/jcm12062149